Surgical Plate Osteosynthesis of Distal Radius Fractures
This study has been terminated.
(Study completed)
Sponsor:
AO Clinical Investigation and Documentation
Collaborators:
Synthes Inc.
AO Hand Expert Group
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00205998
First received: September 13, 2005
Last updated: April 26, 2007
Last verified: April 2007
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Purpose
Primary objective of the study is to demonstrate specific indications for the
surgical treatment of distal radius fractures using the locking compression
plate.
| Condition | Intervention | Phase |
|---|---|---|
|
Distal Radius Fractures |
Device: Locking Compression Plate 2,4mm Device: Locking Compression Plate 3,5mm |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP) |
Resource links provided by NLM:
Further study details as provided by AO Clinical Investigation and Documentation:
Primary Outcome Measures:
- - Document specific indications for the surgical treatment of distal radius fractures using the LCP
Secondary Outcome Measures:
- - Primary reduction and maintenance of reduction of the plate fixation
- - Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring
- - Patient and surgeon satisfaction
- - Analysis of the occured complications
| Enrollment: | 450 |
| Study Start Date: | December 2001 |
| Study Completion Date: | December 2005 |
In addition the differences between the surgical treatment compared to
conservative treatment with respect to fracture healing, functional outcome
and subject satisfaction will be analysed after 6w./6m./1y./2y.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- skeletally mature female and male
- Distal radius and ulnar fractures AO 23
- 10 days after injury
Exclusion Criteria:
- general or local conditions adversely affecting the bone physiology
- ISS >16
- osteosynthesis close to the wrist joint where a different implant has been used
- history of drug and alcohol abuse
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205998
Locations
| United States, Massachusetts | |
| Harvard Medical School | |
| Boston, Massachusetts, United States, 02114 | |
| Germany | |
| BG-Unfallklinik Ludwigshafen | |
| Ludwigshafen, Germany, 67071 | |
| United Kingdom | |
| York District Hospital | |
| York, United Kingdom, YO31 8HE | |
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Synthes Inc.
AO Hand Expert Group
Investigators
| Principal Investigator: | Andreas W Wentzensen, Prof. MD | BG-Unfallklinik Ludwigshafen |
| Principal Investigator: | Jesse B Jupiter, Prof. MD | Harvard Medical School |
| Principal Investigator: | Peter G De Boer, F.R.C.S. | York District Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00205998 History of Changes |
| Other Study ID Numbers: | 01-LCP2,4/3,5-03 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 26, 2007 |
| Health Authority: | Switzerland: Swissmedic Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AO Clinical Investigation and Documentation:
|
Locking Compression Plate Conservative treatment Surgical treatment Radius fractures AO 23 |
Additional relevant MeSH terms:
|
Fractures, Bone Radius Fractures Wounds and Injuries Forearm Injuries Arm Injuries |
ClinicalTrials.gov processed this record on May 16, 2013